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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K083316
Device Name 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Applicant
Topcon Medical Systems, Inc.
310 Ter. Ave.
Suite 201
Cincinnati,  OH  45220
Applicant Contact BARBARA S FANT
Correspondent
Topcon Medical Systems, Inc.
310 Ter. Ave.
Suite 201
Cincinnati,  OH  45220
Correspondent Contact BARBARA S FANT
Regulation Number886.1570
Classification Product Code
OBO  
Date Received11/10/2008
Decision Date 03/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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